STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML

Container, I.v.

HOSPIRA, INC.

The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Sterile Empty Glass Container, 250ml, Sterile Empty Glass Container, 500 Ml, Sterile Empty Glass Container, 1000 Ml.

Pre-market Notification Details

• Device ID: K132276
• 510k Number: K132276
• Device Name: STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML
• Classification: Container, I.v.
• Applicant: HOSPIRA, INC. 275 NORTH FIELD DR. Lake Forest, IL 60045
• Contact: Abigail Ferguson
• Correspondent: Abigail Ferguson; HOSPIRA, INC. 275 NORTH FIELD DR. Lake Forest, IL 60045
• Product Code: KPE
• CFR Regulation Number: 880.5025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-07-22
• Decision Date: 2013-11-12
• Summary: summary